Privacy legislation
Research in Nova Scotia must comply with both the Personal Information International Disclosure Act (PIIDPA) and the Personal Health Information Act (PHIA).
PIIDPA
The Personal Information International Disclosure Protection Act (PIIDPA) came into effect in 2006. It protects privacy by restricting the disclosure of personal information outside Canada, as other countries may not have equivalent data protection laws. Personal information (including participants’ personal health information and researchers’ CVs) may be stored or accessed outside Canada only with the consent of the individual.
PHIA
The Personal Health Information Act (PHIA) came into force on June 1, 2013. This legislation, similar to that in existence in other provinces, deals with the collection, use, disclosure, retention, disposal, and destruction of personal health information. PHIA introduces new requirements for research in Nova Scotia, which has led to modifications to many procedures, practices and forms at Nova Scotia Health.
Canadian Standards and Policies
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
- CAN/HRSO-200.01-2021 Ethical Review and Oversight of Human Research
Health Canada
- Biologics, Radiopharmaceuticals and Genetic Therapies
- Compliance and Enforcement
- Drugs and Health Products: Legislation and Guidelines
- Regulations Amending the Food and Drug Regulations Division 5
- Medical Devices
- Natural Health Products
- Clinical Trials: Frequently Asked Questions
International
- CIOMS International Ethical Guidelines for Biomedical Research
- ICH Guidance E6: Guideline for Good Clinical Practice
- ICH Guidance E8: General Considerations for Clinical Trials
- Nuremberg Code
- Belmont Report
- World Medical Association Declaration of Helsinki
- World Health Organization